GUDIDData
eudamed_udi Primary ID: 07615208340587

IPS Ivocolor Essence 1.8g E05 copper (UDI 07615208340587)

Manufactured by Ivoclar Vivadent AG

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IPS Ivocolor Essence 1.8g E05 copper - Primary ID 07615208340587

Device Regulatory Overview

The IPS Ivocolor Essence 1.8g E05 copper (Model/Catalog Number: 667656) is a medical device manufactured by Ivoclar Vivadent AG. This product is indexed under FDA Product Code / Category Classification Q010699 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1840-2020 View Full Alert →

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🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1838-2020 View Full Alert →

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-st...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1839-2020 View Full Alert →

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-s...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
667656
Product Code / EMDN
Q010699
Device Name
IPS Ivocolor
Database Sync Date
2026-08-09 16:28:45

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of IPS Ivocolor Essence 1.8g E05 copper?

The registered manufacturer of record for IPS Ivocolor Essence 1.8g E05 copper is Ivoclar Vivadent AG.

What is the Primary UDI-DI identifier for IPS Ivocolor Essence 1.8g E05 copper?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07615208340587.

What classification code is assigned to this device?

This device is registered under product classification code Q010699.

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